STORAGE AND DISPOSAL OF EXHIBIT BATCHES OF DRUG PRODUCTS
PURPOSE:
To describe a procedure for Storage and Disposal of Exhibit Batches of Drug Products.
SCOPE: This standard operating procedure (SOP) is applicable to the exhibit batches of Drug Products manufactured and packed in the formulation manufacturing facilities.
RESPONSIBILITY:
Production:
Transfers the exhibit batches to warehouse.
Warehouse:
To Store the exhibit batches in warehouse at recommended storage condition.
To send the exhibit batch for destruction to ETP after due period of storage.
Effluent Treatment Plant (ETP):
Arrange for destruction of exhibit batch received for disposal.
Maintains documentation of disposal.
Technology Transfer/ Research and Development (R&D):
Verification of disposal of exhibit batch.
Regulatory Affairs (RA):
Intimates the regulatory approvals of products to QA.
Verification of the intimation for disposal of exhibit batch.
Quality Assurance:
Provides the intimation for disposal of exhibit batch to warehouse.
Approves exhibit batch destruction after due period of storage.
DEFINITIONS:
Batches manufactured and intended for regulatory filing.
PROCEDURE:
Storage of Exhibit Batch:
Warehouse personnel shall receive the exhibit batch from production.
Warehouse personnel shall store the exhibit batch in Finished Good (FG) store in the Warehouse as per storage condition of the product.
The exhibit batch (es) shall be stored in warehouse till approval of respective regulatory approval or till product expiry whichever is later.
In case approval received after expiry, site QA shall inform to warehouse for disposal of the stored exhibit batch, however, in case if regulatory approval is already receive prior to product expiry, warehouse shall initiated destruction of the exhibit batches after product expiry. Warehouse department shall fill the necessary details in Annexure (Disposal of Exhibit batch.
Disposal of Exhibit Batches:
Before destruction of exhibit batch, prior approval shall be taken from Technology Transfer/ R&D, Regulatory Affairs, QA head, Plant Head, Account department on the “Destruction Format”.
The exhibit batch for destruction will be labelled as per site labelling procedure.
After approval from concern department e.g. Technology Transfer/ R&D, Regulatory Affairs, Plant head, Account department and QA head, the exhibit batch shall transfer to ETP along with approved permission of Disposal of Exhibit batch.
After receiving of the material from warehouse; ETP personnel shall ensure the information mentioned in the permission letter of Disposal of Exhibit batch with respect to Product Name, quantity of material, reason for destruction and verify with the physical material received.
ETP department shall destroy the material as defined in the site specific SOPs and maintain the records.
In case a batch fails to meet specification during stability studies or due to any reason the exhibit batch/ strength is withdrawn, the reference sample of the batch stored in warehouse can also be disposed off as per procedure mentioned above.
ABBREVIATIONS:
ETP : Effluent Treatment Plant
FG : Finished Goods
RA : Regulatory Affairs
R&D : Research and Development
REFERENCES:
Guidance for Industry ANDAs: Stability Testing of Drug Substances and
Products Q & A – Centre for Drug Evaluation and Research (CDER) May 2014
ANNEXURES:
Annexure 1 : Disposal of Exhibit batch
